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Clinical Trial Summary

This mechanistic study will be the first study to assess the efficacy of [18F]GE-226 to target HER2 expression in patients with metastatic breast cancer. The study will establish the pharmacokinetics of [18F]GE-226 and the optimum time-point for performing static scans in this patient population.

Clinical Trial Description


- To determine the uptake in tumour lesions and normal tissue of [18F]GE‐226 and compare the difference between patients with HER2 positive and HER2 negative lesions. Uptake will be quantified by semi‐quantitative (SUV, AUC) and fully quantitative parameters (Ki in the case of irreversible uptake, and binding potential in the case of reversible uptake)

- To determine the optimal imaging time point for [18F]GE‐226


- To determine the safety and toxicity of [18F]GE‐226 PET in humans

- To determine if [18F]GE‐226 can distinguish between HER2 amplified and HER2 non‐amplified breast tumours

- To determine the metabolism of [18F]GE‐226 in human subjects


• To explore circulating biomarkers that may be related to [18F]GE‐226 uptake and to investigate if treatment modulates [18F]GE‐226 ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03827317
Study type Interventional
Source Imperial College London
Contact HERPET Trial Coordinator
Phone 0207 59 42804
Status Recruiting
Phase N/A
Start date January 2019
Completion date January 2021

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